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Pediatric Enhanced Surveillance Study (PESS)

2015年12月4日更新者：Elaine J. Abrams, MD、Columbia University

Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa

The Pediatric Enhanced Surveillance Study is a three part study of HIV-infected infants and children in South Africa to examine, clinical, immunologic, virologic, metabolic, psychosocial and behavioral outcomes. This study has two parts: (1) comprehensive de-identiﬁed records review of all HIV-infected children enrolled in at the pediatric Wellness and ART clinics at the ﬁve study sites; and (2) a prospective cohort surveillance study with active consented enrollment with 12-24 months of follow-up. As part of the prospective cohort, the study will aim to collect outcomes on children lost to follow-up, including causes of death through review of death certiﬁcates in the clinical chart and through verbal autopsy reports. The study will provide insights into overall outcomes for the larger pediatric patient populations in the province and South Africa. This work is designed in collaboration with the provincial health authorities of the Eastern Cape Department of Health (EC), The International Center for acquired immune deficiency syndrome (AIDS) Care and Treatment Programs (ICAP) South Africa and Center of Disease Control (CDC)-South Africa in support of the South African National ART Program for Children and aims to collect and analyze accurate, relevant and useful information that will be available on children seen at facilities. For the prospective cohort study, we will aim to enroll 400 children newly initiated on ART at 5 health facilities in the Eastern Cape of South Africa who will be actively followed for up to 24 months.

研究概览

地位

完全的

条件

详细说明

South Africa is one of the countries hardest hit by the HIV/AIDS epidemic. There are more than 5 million people living with HIV in South Africa, including 280,000 children under the age of 15. Most HIV positive children acquire infection through mother-to-child transmission; in South Africa 29.3% of pregnant women attending antenatal services are HIV-infected. Furthermore, it is estimated that HIV is the cause of 35% of all deaths in children under five in South Africa. The South African government began a national rollout of HIV treatment for adults and children in 2003. As of 2007, an estimated 32,060 children under the age of 15 were receiving antiretroviral therapy (roughly 30% of those in need). There is an urgent need to obtain more comprehensive, in-depth, profiles of children enrolled in HIV care with a focus on documenting outcomes, particularly timing and causes of death, reasons for loss to follow-up, timing and frequency of treatment failure, adverse events, metabolic complications and psychosocial aspects of HIV disease.

研究类型

观察性的

注册 (实际的)

396

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

南非
- Amathole
  - East London、Amathole、南非
    - Cecilia Makiwane Hospital
  - East London、Amathole、南非
    - Frere Hospital
- Nelson Mandela Bay
  - Port Elizabeth、Nelson Mandela Bay、南非
    - Dora Ngiza Hospital
  - Port Elizabeth、Nelson Mandela Bay、南非
    - Kwazakhele Community Health Center
  - Port Elizabeth、Nelson Mandela Bay、南非
    - Motherwell Community Health Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1个月至 12年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Human immunodeficiency virus (HIV)-infected children accessing HIV care and treatment services in the Eastern Cape of South Africa are the population of interest for the overall study.

Records review: All children with a record of care at the study facilities in the Wellness or antiretroviral (ART) clinic will form the study population.
Prospective cohort: ART-naïve children receiving care at participating sites who have reached eligibility for ART and consent to participate will form the study population. The sample for the study will be a subset of all children enrolled and receiving care at these public health care facilities.

描述

Inclusion Criteria:

The child is eligible for antiretroviral therapy (ART) initiation based on the South African Pediatric HIV guidelines.
The child has documentation of being HIV-infected by a positive HIV-Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), detectable HIV ribonucleic acid (RNA) viral load or a positive HIV antibody test (>18 months of age).
The child has no prior history of treatment with ART other than prophylaxis for preventing mother to child transmission (PMTCT) (may be initiating ART on day of enrollment in study).
The child is between 1 month and 12 years of age.
The parent or legal guardian provides written consent for participation.
The child provides assent for participation based on South African guidance for minors.

Exclusion Criteria:

Any subject not meeting all of the above inclusion criteria will not be eligible for the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Prospective Cohort The prospective cohort surveillance will be built upon and support the routine clinical care, visit schedule and monitoring system at each study site. Eligible HIV-infected ART naïve children who are accessing care at study sites will be recruited sequentially for study enrollment. Children enrolled in the surveillance study will attend study visits co-scheduled to coincide with routine clinical visits. Study nurses will: review routinely collected information; conduct questionnaires with caregiver and child; conduct additional assessments of child; contact the caregiver by phone or through home visits for active follow-up for up to 24 months; and conduct active follow-up including appointment reminders by means of phone calls and defaulter tracking.

团体/队列

Prospective Cohort

The prospective cohort surveillance will be built upon and support the routine clinical care, visit schedule and monitoring system at each study site. Eligible HIV-infected ART naïve children who are accessing care at study sites will be recruited sequentially for study enrollment. Children enrolled in the surveillance study will attend study visits co-scheduled to coincide with routine clinical visits. Study nurses will:

review routinely collected information;
conduct questionnaires with caregiver and child;
conduct additional assessments of child;
contact the caregiver by phone or through home visits for active follow-up for up to 24 months; and
conduct active follow-up including appointment reminders by means of phone calls and defaulter tracking.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Proportion of children alive and in care at 12 and 24 months after treatment initiation 大体时间：Up to 24 months	We will measure the proportion of children alive and in care at 12 and 24 months after treatment initiation amount prospective cohort participants through routine clinical and study visits.	Up to 24 months

次要结果测量

结果测量	措施说明	大体时间
Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services 大体时间：Up to 24 months	We will describe the proportion of the children enrolled in HIV care and treatment services at the study facilities who start treatment and are retained in care for 6, 12, 24, 36 and 48 months by reviewing clinical records at each facility.	Up to 24 months
Proportion of children lost to follow-up 大体时间：Up to 24 months	We will describe the proportion of children lost to follow-up after enrollment in care and in those starting treatment by reviewing clinical records of study participants.	Up to 24 months
Proportion of children with documented deaths 大体时间：Up to 24 months	We will describe proportion of children with documented deaths and causes of deaths and time to death (from enrollment) by reviewing clinical records of participants.	Up to 24 months
Proportion of children who are virologically suppressed 大体时间：Up to 24 months	We will measure the proportion of children who are virologically suppressed (< 400 copies/mL, per South African National Guidelines) at 12 and 24* months after treatment initiation in the prospective cohort through routine clinical and study visits.	Up to 24 months
Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts 大体时间：Up to 24 months	We will measure the proportion of children, aged 2 to 5 years, on ART with CD4% <10% at 12, 24* months after treatment initiation and children older than 5 years on ART with CD4 count of < 100 at 12, 24 months after treatment initiation. These outcomes will be measured in participants of the prospective cohort who will give additional blood samples during routine clinical care.	Up to 24 months
Proportion of children on antiretroviral therapy (ART) progressing to WHO Stage 4 disease 大体时间：Up to 24 months	We will measure the proportion of children on ART progressing to WHO Stage 4 disease at 12 and 24 months after treatment initiation in the prospective cohort.	Up to 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Columbia University

合作者

Centers for Disease Control and Prevention

调查人员

首席研究员：Elaine Abrams, MD、ICAP-NY, Columbia University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (实际的)

2015年10月1日

研究完成 (实际的)

2015年10月1日

研究注册日期

首次提交

2014年1月13日

首先提交符合 QC 标准的

2014年1月21日

首次发布 (估计)

2014年1月23日

研究记录更新

最后更新发布 (估计)

2015年12月7日

上次提交的符合 QC 标准的更新

2015年12月4日

最后验证

2015年12月1日